INDICATIONS AND USAGE
Sildenafil treats PAH by relaxing the blood vessels in the lungs to allow blood to flow easily. If you are taking sildenafil to treat erectile dysfunction, you should know that it does not cure erectile dysfunction or increase sexual desire.
What happens if I miss a dose?
If you take more medicine than you have been told to take contact your doctor immediately. Taking more Sildenafil Oral suspension than you should may increase the risk of known side effects. If you forget to take Sildenafil Oral suspension If you forget to take Sildenafil Oral suspension, take a dose as soon as you remember, then continue to take your medicine at the usual times. Do not take a double dose to make up for a forgotten dose. If you stop taking Sildenafil Oral suspension Suddenly stopping your treatment with Sildenafil Oral suspension may lead to your symptoms getting worse.
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Do not stop taking Sildenafil Oral suspension unless your doctor tells you to. Your doctor may tell you to reduce the dose over a few days before stopping completely. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following side effects, you should stop taking Sildenafil Oral suspension and contact a doctor immediately (see also section 2): if you experience sudden decrease or loss of vision (frequency not known) if you have an erection, which lasts continuously for more than 4 hours.
Warnings for people with certain health conditions
Prolonged and sometimes painful erections have been reported in men after taking sildenafil (frequency not known). Side effects reported very commonly (may affect more than 1 in 10 people) were headache, facial flushing, indigestion, diarrhoea and pain in the arms or legs. Side effects reported commonly (may affect up to 1 in 10 people) included: infection under the skin, flu-like symptoms, inflammation of the sinuses, reduced number of red blood cells (anaemia), fluid retention, difficulty sleeping, anxiety, migraine, shaking, “pins and needles”-like sensation, burning sensation, reduced sense of touch, bleeding at the back of the eye, effects on vision, blurred vision and light sensitivity, effects on colour vision, eye irritation, bloodshot eyes /red eyes, vertigo, bronchitis, nosebleed, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, heartburn, piles, abdominal distension, dry mouth, hair loss, redness of the skin, night sweats, muscle aches, back pain and increased body temperature. Side effects reported uncommonly (may affect up to 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men. Skin rash and sudden decrease or loss of hearing and decreased blood pressure have also been reported at an unknown frequency (frequency cannot be estimated from the available data). Sildenafil does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).
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| Viagra Generic | 25mg | 10 Pills | 25.19€ 23.99€ | |
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| Kamagra Soft Tabs | 100mg | 180 + 8 Pills | 425.45€ 405.19€ | |
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Sildenafil comes as a tablet and suspension (liquid) to take by mouth.
5.6 Hearing Loss
Higher doses should not be used in children. The oral suspension must be shaken well before use. Open the bottle: press the cap and turn it anticlockwise (figure 1). Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3).
Allergy warning
Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure 5). Fill the syringe with a small amount of suspension by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C). Turn the bottle the right way up (figure 6A).
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Remove the syringe from the adaptor (figure 6B). Close the bottle with the plastic screw cap. Empty the contents of the syringe into your mouth. After dosing, wash the syringe with water only (figure 7). If you take more Sildenafil Oral suspension than you should You should not take more medicine than your doctor tells you to. If you are taking sildenafil to treat erectile dysfunction, follow your doctor's directions and the guidelines in this paragraph.
Proper Use
The following serious adverse events have been reported commonly (may affect up to 1 in 10 people); pneumonia, heart failure, right heart failure, heart related shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral infection in the stomach and intestines, urinary tract infections and tooth cavities. The following serious adverse events were considered to be treatment related and were reported uncommonly (may affect up to 1 in 100 people), allergic reaction (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsion, irregular heart-beat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to disrupted airflow. Side effects reported very commonly (may affect more than 1 in 10 people) were headache, vomiting, infection of the throat, fever, diarrhoea, flu and nosebleed. Side effects reported commonly (may affect up to 1 in 10 people) were nausea, increased erections, pneumonia and runny nose. If you get any side effects, talk to your doctor or nurse.
5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease
You can sildenafil 50g also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. or search for MHRA Yellow Card in the Google Play or Apple App Store. Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions.
12.2 Pharmacodynamics
Do not store above 25°C after first opening of the bottle. Discard after 90 days of first opening. Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month. Do not use this medicine if you notice that the suspension becomes discoloured or shows any signs of deterioration. Take sildenafil as needed before sexual activity.
Dosing information
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment. Contents of the pack and other information The active ingredient is Sildenafil (as citrate). Each 1 ml of Sildenafil Oral suspension contains 10 mg of Sildenafil.
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What Sildenafil Oral suspension looks like and contents of the pack Sildenafil Oral suspension is a white to off white suspension. This medicine is supplied in amber glass bottle with a white child resistant tamper evident closure containing 122 ml of liquid product. The package contains a 2 ml oral syringe with a polypropylene body, purple HDPE plunger, graduations printed at 0.5 ml 1.0 ml, 1.5 ml and 2.0 ml together with a low density polyethylene bottle adaptor. The Marketing Authorisation Holder and Manufacturer is: Rosemont Pharmaceuticals LtdYorkdale Industrial ParkBraithwaite StreetLeedsLS11 9XEUK LM Manufacturing LimitedSandretto BuildingCavalry Hill Industrial ParkWeedonNorthamptonNN7 4PPUnited Kingdom This leaflet was last revised in April 2024 DescriptionDosage FormOral SuspensionIndicationPulmonary Arterial hypertensionBrand NameRevatio®TE CodeABLactoseNoGlutenNoColorOff-White to Light Yellow PowderShapeNAMarkingsNAStorage ConditionBEFORE RECONSTITUTION: Store below 30°C (86°F) in the original package in order to protect from moisture. AFTER RECONSTITUTION: Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36°F to 46°F) Do not freeze.
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Discard any unused portion 60 days after reconstitution.PACK SIZE: “112 mL following ReconstitutionNDC#: 27241-0175-29Click to View Package Insert Click to View Material Data Safety Sheet Revatio ® is registered trademark of Pfizer Sildenafil (Viagra) is used to treat erectile dysfunction (impotence; inability to get or keep an erection) in men. Sildenafil (Liqrev, Revatio) is used to improve the ability to exercise in adults (Liqrev, Revatio) and children 1 year of age and older (Revatio) with pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness). Sildenafil is in a class of medications called phosphodiesterase (PDE) inhibitors. Sildenafil treats erectile dysfunction by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. The best time to take sildenafil is about 1 hour before sexual activity, but you can take the medication any time from 4 hours to 30 minutes before sexual activity.
| Country | Approval Status | Regulatory Body | Remarks |
|---|---|---|---|
| United States | Approved for pulmonary hypertension, off-label for ED | FDA | Prescription medication |
| European Union | Approved with similar indications | EMA | Prescription required |
| India | Approved for ED and pulmonary hypertension | CDSCO | Over the counter in some regions |
| Canada | Approved, prescription-only | Health Canada | Strict prescribing guidelines |
Sildenafil usually should not be taken more than once every 24 hours.
- Sildenafil works by relaxing blood vessels to improve blood flow.
- Used primarily to treat erectile dysfunction and pulmonary hypertension.
- Syrup formulations may be used in children or those with swallowing difficulties.
- Proper storage of sildenafil syrup is essential to maintain efficacy.
- It is important to follow a healthcare provider’s instructions when using.
If you have certain health conditions or are taking certain medications, your doctor may tell you to take sildenafil less often. You can take sildenafil with or without food. However, if you take sildenafil with a high-fat meal, it will take longer for the medication to start to work.
- Sildenafil syrup is an off-label form of erectile dysfunction medication.
- It's designed for easier ingestion compared to tablets.
- Not approved by most regulatory agencies for syrup form.
- Dosing and safety information are less documented for syrup.
- Usually, sildenafil is available in tablet form, not syrup.
If you are taking sildenafil to treat PAH, you will probably take sildenafil three times a day with or without food. Take sildenafil at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Do not take more or less of it or take it more often than prescribed by your doctor.
- Sildenafil can cause visual disturbances like blurred vision.
- Alcohol consumption may increase side effects when using sildenafil.
- The syrup should be stored at room temperature away from light.
- Patients should avoid heavy meals before taking sildenafil.
- Regular monitoring is recommended for long-term use.
Shake the liquid well for 10 seconds before each use to mix the medication evenly. Use the oral syringe provided with your medication to measure and take your dose. Follow the manufacturer's directions to use and clean the oral syringe. Do not mix the liquid with other medications or add anything to flavor the medication. If you are taking sildenafil for erectile dysfunction, your doctor will probably start you on an average dose of sildenafil and increase or decrease your dose depending on your response to the medication.
- Contraindications include hypersensitivity to sildenafil.
- Patients with heart conditions should consult a cardiologist before use.
- Sildenafil’s safety profile is well-studied in adults.
- The syrup should not be used with children without medical advice.
- Proper disposal of unused syrup is important to avoid misuse.